Description of the Analgesia Obtained With the Anesthesiological Protocols Currently Used in Breast Surgery

March 12, 2020 updated by: Gianluca Villa, Careggi Hospital
This study aims to describe the pain-relieving effect obtained with the current post-surgery pain control methods used in breast surgery by measuring the painful sensation and the consumption of opioids in the first 24 post-surgery hours. It also aims to describe the appearance of any complications such as post-surgery nausea and vomiting. Current anesthesia involves the combined use of intravenous painkillers and anti-inflammatory drugs such as acetaminophen, ketorolac, tramadol or morphine (the latter via PCA system = patient-controlled analgesia) or for local administration at the surgical site level ( local anesthetics). It is also proposed to describe the intensity and interference of pain in daily activities

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the second most common in the world and the most frequent in the female population. In Italy, around 48,000 new cases were diagnosed in 2013. Every year patients undergoing surgical procedures in the region of the breast and armpit, like other surgical areas, report a significant incidence of acute postoperative pain which in 25-60% of cases can progress to chronic pain and therefore it needs a timely and effective control.

Breast surgery is associated with a high incidence of postoperative nausea and vomiting (PONV) whose etiology is multifactorial and includes factors such as age, type of intervention, positive history of PONV and, primarily, the amount of morphine used to ensure postoperative analgesia, the type of anesthesia and the intensity of postoperative pain.

The conventional anesthesiological approach to breast surgery involves the use of general anesthesia and postoperative analgesic therapy based on opiates and fans. Some techniques of locoregional anesthesia such as paravertebral block, thoracic peridural analgesia and intercostal block, associated with sedoanalgesia or general anesthesia, have joined the standard anesthesiological conduct helping to improve pain control, response to surgical stress, post-operative respiratory function, the incidence of thromboembolic events and it seems they can also contribute to reducing the incidence of distant metastases. In addition, making possible a reduced use of opiates further decrease the incidence of PONV. As part of this multimodal approach to anesthesia and analgesia for breast surgery, PECS Block I and II and the Serratus Plane Block (SPB) have recently been introduced into clinical practice.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy, 50100
        • Azienda Ospedaliero Universitaria Careggi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients who in accordance with the inclusion and exclusion criteria have given their consent to the processing of personal data will be considered for analysis. All patients will undergo the anesthesiological and surgical treatment foreseen for the patient's clinical condition and in no case will the patients undergo a modification of the normal diagnostic-therapeutic path due to participation in this study.

Description

Inclusion Criteria:

  • Female gender
  • Age> 18 years;
  • Patients in ASA class <4;
  • Planned mastectomy surgery, simple mastectomy with immediate reconstruction, mastectomy with sentinel-lymph node biopsy, modified radical mastectomy (unilateral or bilateral);
  • Absence of allergies or hypersensitivity reported and / or documented to drugs used routinely for post-operative analgesia;
  • Absence of inflammatory changes at the surgical site level;
  • Presence of the patient's informed consent to the processing of personal data;

Exclusion Criteria:

  • Known alterations of coagulation;
  • Known cardiac arrhythmias (atrial sinus block I, II, III type, atrioventricular block I, II and III type);
  • Documented renal failure (patient undergoing renal replacement therapy, or creatininemia ≥ 2 mg / dl);
  • Severe hepatic insufficiency (Child-Plugh class III and IV); Seizure states (absences, seizures of large and / or small epileptic disease);
  • Respiratory failure (PaO2 ≤ 60mmHg PaCO2≥ 50mmHg);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with breast cancer
Female patients (age> 18yrs) in ASA class <4; candidate for a planned surgery for simple mastectomy, simple mastectomy with immediate reconstruction, mastectomy with sentinel node biopsy, modified radical mastectomy (unilateral or bilateral)
Drug: Analgesics
All patients will undergo the anesthesiological and surgical treatment provided for the patient's clinical conditions and in no case will the patients undergo a change in the normal diagnostic-therapeutic path due to participation in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the change of level of anesthesia
Time Frame: Up to 24 hours after surgery

Describing the level of analgesia obtained in the first 24 hours post-operative in patients undergoing simple mastectomy, mastectomy with immediate reconstruction with expander or retropectoral prosthesis, mastectomy with sentinel node biopsy and radical mastectomy modified with the anesthesiological protocols used routinariamentally. Analgesia will be evaluated every 6 hours and for the first 24 post-operative hours (at 0, 6, 12, 18, 24 hours from the end of the surgical intervention) through the NRS (Numerical Rating Scale).

The Numerical Rating Scale is a pain sensation rating scale at points where the patient chooses a value ranging from 0 (no pain) to 10 (maximum pain). From 1 to 3 it is considered mild pain, from 4-7 moderate, from 8-10 severe.
Up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describing the total amount of morphine used in the first 24 post-operative hours.
Time Frame: 24 hours after surgery
The total amount of morphine used will be expressed in milligrams of morphine used by the patient in the first 24 hours post-operative normalized per kilogram of body weight (mg / kg).
24 hours after surgery
Describing the incidence of PONV (Postoperative Nausea and Vomiting).
Time Frame: 24 hours after surgery
The incidence of PONV, measured at 0, 6, 12, 18 and 24 hours will be expressed in terms of percentage.
24 hours after surgery
Describing of change in severity of PONV (Postoperative Nausea and Vomiting).
Time Frame: 24 hours after surgery
The incidence of PONV, measured at 0, 6, 12, 18 and 24 hours will be expressed in terms of percentage. The severity of PONV will be expressed according to the following evaluation scheme: absence of nausea = 0, mild nausea = 1, moderate = 2, severe nausea or vomiting = 3
24 hours after surgery
Description of the change of the intensity of pain on daily activities reported by patients undergoing breast surgery.
Time Frame: 3 months after surgery
The painful sensation is assessed by six questions on the quality of pain experienced in the previous 24 hours; for each question, an answer corresponding to a numerical value from 0 (no pain) to 10 (maximum) according to the Numerical Rating Scale (NRS) is requested and recorded. In addition, the percentage of relief provided by analgesic drugs, possibly taken, is investigated by administering a question and recording a percentage value, from 0% (minimum) to 100% (maximum), referring to the percentage sensation of pain relief. A second question is requested related to the type of drug possibly taken. At the end of the questionnaire, an overall score is calculated regarding the questions on the intensity of pain (0-40, 0-10 points for each answer to questions 3 to 6). A score of 0 (no pain) to 10 (maximum pain) is referred to the percentage of relief given by the analgesics corresponding to the value given in percentage / 10.
3 months after surgery
Description of the change of the interference of pain on daily activities reported by patients undergoing breast surgery.
Time Frame: 3 months after surgery
The interference of pain includes the evaluation of 7 fields referring to which patients can express for each field, according to a numerical scale from 0 (minimum) to 10 (maximum), how much pain interferes. The numerical scale from 0-10 allows to record a response that varies between 0 = no interference in the activity, and 10 = completely interferes with the activity. This scale has been validated according to psychometric criteria. At the end of the questionnaire, an overall score is calculated regarding the questions on the intensity of pain (0-40, 0-10 points for each answer to questions 3 to 6). A score from 0-10 refers to the percentage of relief given by the analgesics corresponding to the value given as a percentage / 10. An overall score is calculated from 0 (no interference) to 70 (maximum interference), from 0 to 10 for each of the seven fields.
3 months after surgery
Description of the change of the incidence and impact on daily activities of the pain reported by patients undergoing breast surgery.
Time Frame: 3 months after surgery
The incidence on daily pain activities will be assessed 3 months after surgery through the Brief Pain Inventory (BPI ) scale in the Italian validated version. The Brief Pain Inventory questionnaire evaluates the multidimensional experience of pain through two domains: the intensity of pain and the interference of pain (see the following outcome) in daily activities.An overall final score is calculated from 0 (minimum) to 120 (maximum) corresponding to the multidimensional experience of pain, obtained from outcomes 5 and 6
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Careggi Hospital

Investigators

  • Principal Investigator: Carmelo Guido, MD, Careggi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2016

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEAVC OSS. 16.246

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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